Skip to main content

Table 4 Comparative efficacy of virtual RCTs comparing drug D1 and drug D2

From: The “RCT augmentation”: a novel simulation method to add patient heterogeneity into phase III trials

Re-included subpopulations Average comparative efficacy of D1 vs. D2 (ΔCGI-S for D1 minus ΔCGI-S for D2) Standard deviation of comparative efficacy D1 vs. D2 (ΔCGI-S for D1 minus ΔCGI-S for D2)
Relaxed eligibility criteria Illness duration between 1 and 3 years − 0.113 0.067
1 past suicide attempt −0.122 0.064
Private practice −0.092 0.064
Alcohol abuse −0.064 0.066
Drug abuse −0.066 0.064
Illness duration between 1 and 3 years + 1 past suicide attempt − 0.171 0.072
Illness duration between 1 and 3 years + private practice − 0.127 0.071
Illness duration between 1 and 3 years + alcohol abuse − 0.110 0.067
RCT population −0.066 0.062
SOHO “real-world population” −0.124 0.084
  1. The results were generated in two parallel study arms with 250 patients each